CAMINO® 110-4HMT (REF 1104HMT)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00382830047531), received between Apr 19, 2023 and Sep 26, 2025 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

2 other recalls cover devices cleared under the same FDA submission (K962928); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 26, 2025Break; Break

  MICRO VENTRICULAR BOLT ICP / TEMP. MONITORING KIT - DURING THE IMPLANTATION PROCESS, IT WAS FOUND THAT THE SILICONE TUBE OF THE VENTRICULAR CHANNEL WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23157907 ↗
• MalfunctionNov 19, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem

  MICRO VENTRICULAR BOLT ICP / TEMP. MONITORING KIT - USER COULD NOT CONTINUE WITH PROCEDURE DUE TO PRESSURE ISSUES. THE PATIENT WAS ADMITTED TO THE NEUROSURGERY WARD OF THE HOSPITAL DUE TO CEREBRAL HERNIA. THE PATIENT WAS SCHEDULED FOR SURGERY. INTRAOPERATIVE INTRACRANIAL PRESSURE MONITORING COULD NOT MEASURE THE PRESSURE, THE OPERATION WAS DELAYED, AND THE READING RETURNED TO NORMAL AFTER REPLACING NEW DEVICES. NO INJURIES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20722328 ↗
• MalfunctionApr 15, 2024Leak/Splash; Leak/Splash

  MICRO VENTRICULAR BOLT ICP / TEMP. MONITORING KIT - LEAKAGE OF CSF. NO DELAY IN SURGERY. NO INJURIES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19106407 ↗
• InjuryApr 19, 2023Break; Fracture; Break; Fracture

  PART 110-4HMT. THE INTRACRANIAL PRESSURE PROBE WAS INTERVENED BY VENTRICULAR PUNCTURE OPERATION ON (B)(6) 2020. THE OPERATION WAS SUCCESSFUL, AND THE INTRACRANIAL PRESSURE PROBE WAS REMOVED ON (B)(6) 2020. SUBSEQUENTLY, THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL FOR FURTHER TREATMENT. PART OF THE INTRACRANIAL PRESSURE PROBE WAS FOUND TO REMAIN INSIDE THE SKULL DURING TREATMENT IN AN EXTERNAL HOSPITAL, WHICH WAS REPORTED TO THE HOSPITAL ON (B)(6) 2023. THE CATHETER IN QUESTION HAS BEEN DISCARDED, THEREFORE NOT AVAILABLE FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16773533 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K962928. One submission often covers many models, so check the product and lot details in each record.

• Z-0602-2014 · Nov 26, 2013 · Terminated
  Integra Camino Advanced Monitor with Waveform Display Model CAM01 Integra Neurosciences, 311 Enterprise Dr Plainsboro, NJ 08536 USA The Camino Advanced Monitor is a compact, porta
• Z-0944-2012 · Oct 20, 2011 · Terminated
  Integra PAC1 Mod 2 Cables used with the Integra MPM, CAM01 Monitors